Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension

July 7, 2014 updated by: Boehringer Ingelheim

Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension On a Controlled Sodium Diet (100 mmol/Day)

Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate hypertensive patients on a controlled sodium diet as well as to explore the effects of telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was assessed whether the natriuretic effect disappears after treatment when telmisartan is stopped. The effects of telmisartan on seated clinic blood pressure and the relationship between urine sodium loss and decrease in ambulatory blood pressure after the first dose were assessed descriptively. Assessment of safety was also considered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild-to-moderate hypertension as defined by a morning mean diastolic blood pressure from ≥ 90 and ≤ 115 mmHg and a mean systolic blood pressure ≤ 200 mmHg after five minutes in the seated position at the end of three weeks of placebo run-in treatment
  • Male or female patients between 18 and 65 years of age, inclusive. Patients 60 to 65 years of age must have a screening 24-hour urine creatinine clearance rate of ≥ 1 mL/sec
  • Ability to provide written informed consent

Exclusion Criteria:

  • Pre-menopausal women (last menstruation ≤ one year to start of screening)

  • Post-menopausal women (last menstruation > one year from start of screening or have had a hysterectomy and oophorectomy)

    • Who have < three months of stable estrogen replacement therapy at screening
    • Who will be on progesterone therapy at any time during the trial
  • Known or suspected secondary hypertension

  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than two times the upper limit of reference range
    • Serum creatinine greater than 2.3 mg/dL
  • Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
  • NYHA (New York Heart Association) functional class CHF (chronic heart failure) III-IV
  • Unstable angina, myocardial infarction or cardiac surgery within the preceding three months
  • Stroke within the preceding six months
  • PTCA (percutaneous transluminal coronary angioplasty) within the preceding three months
  • History of angioedema
  • Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant cardiac arrhythmias as determined by the clinical Investigator
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
  • Administration of digoxin or other digitalis-type drugs
  • Patients with insulin-dependent and non-insulin-dependent diabetes mellitus
  • History of drug or alcohol dependency
  • Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II antagonists, α-blockers, β-blockers, calcium channel antagonists, direct vasodilators at any time during the trial
  • Administration of other non-antihypertensive medications known to affect blood pressure (e.g., oral corticosteroids, MAO (monoamine oxidase) inhibitors, nitrates) at any time during the trial
  • Chronic administration of high doses of NSAIDS and aspirin (e.g., ibuprofen for rheumatoid arthritis and osteoarthritis in total daily dose in excess of 1600 mg, aspirin in excess of 2 Gm per day)
  • Chronic use of salt substitutes containing potassium chloride; potassium supplements; extreme dietary restrictions
  • Clinically significant sodium depletion as defined by a serum sodium level less than 130 mEq/L
  • Clinically significant hyperkalemia as defined by a serum potassium level greater than 6.0 mEq/L. Clinically significant hypokalemia as defined by a serum potassium level less than 3.0 mEq/L
  • Patients receiving any investigational therapy within one month of signing the informed consent form. Note that patients who have participated in previous telmisartan studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
  • Known hypersensitivity to any component of telmisartan
  • Any other clinical condition which, in the opinion of the principal Investigator, would not allow safe completion of the protocol and safe administration of trial medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telmisartan, low dose
3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment ,1 week placebo wash-out (controlled sodium diet)
Drug: Placebo
Drug: Telmisartan, low dose
Experimental: Telmisartan, high dose
3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet)
Drug: Placebo
Drug: Telmisartan, high dose
Placebo Comparator: Placebo
3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cumulative urinary sodium loss
Time Frame: 0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6
0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cumulative urine sodium loss
Time Frame: 0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
Changes in body weight
Time Frame: 24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
Changes in plasma norepinephrine
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in renin activity
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in aldosterone
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in urine potassium
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in creatinine chloride
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in bicarbonate
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in uric acid
Time Frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Cumulative urinary sodium gain during wash-out period
Time Frame: 0-24 hours post-dose on days from day 15 to 22
0-24 hours post-dose on days from day 15 to 22
Changes in seated clinic blood pressure
Time Frame: Baseline and day 14
Baseline and day 14
Changes in 24 hour ambulatory Blood Pressure (ABPM) after the first dose of telmisartan
Time Frame: Day 0
Day 0
Number of patients with adverse events
Time Frame: up to 50 days
up to 50 days
Number of patients with abnormal findings in physical examination
Time Frame: Baseline and day 22
Baseline and day 22
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Time Frame: Baseline and day 22
Baseline and day 22
Number of patients with abnormal changes in laboratory parameters
Time Frame: Baseline and day 22
Baseline and day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 502.255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings